ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Preparation of elastomeric closures for testing
Annex A (normative) - Test for penetrability
Annex B (normative) - Test for fragmentation
Annex C (normative) - Test for self-sealing and dye
solution tightness
Annex D (normative) - Test for dye solution tightness
Bibliography

Defines requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

DocumentType	Standard
Pages	19
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
ISO 8871-5:2016	Identical
EN ISO 8871-5:2016	Identical

ISO 8536-2:2010	Infusion equipment for medical use — Part 2: Closures for infusion bottles
ISO 8362-4:2011	Injection containers and accessories Part 4: Injection vials made of moulded glass
ISO 8536-6:2016	Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
ISO 8362-3:2001	Injection containers and accessories Part 3: Aluminium caps for injection vials
ISO 8362-6:2010	Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
DIN ISO 8536-6:2017-09	INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016)
ISO 8362-1:2009	Injection containers and accessories Part 1: Injection vials made of glass tubing
DIN EN ISO 8362-3:2003-10	INJECTION CONTAINERS FOR INJECTABLES AND ACCESSORIES - PART 3: ALUMINIUM CAPS FOR INJECTION VIALS

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DIN EN ISO 8871-5:2017-03

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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